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Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)

9. august 2011 oppdatert av: Astellas Pharma Inc

Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Studietype

Intervensjonell

Registrering (Faktiske)

501

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
    • California
      • Los Angeles, California, Forente stater, 90057
      • Palo Alto, California, Forente stater, 94304
      • San Diego, California, Forente stater, 92123
      • San Francisco, California, Forente stater, 94115
      • San Francisco, California, Forente stater, 94143
    • Colorado
      • Denver, Colorado, Forente stater, 80262
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
      • Washington, District of Columbia, Forente stater, 20007
    • Florida
      • Miami, Florida, Forente stater, 33136
      • Tampa, Florida, Forente stater, 33066
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
      • Chicago, Illinois, Forente stater, 60612
    • New Jersey
      • Livingston, New Jersey, Forente stater, 07039
      • New Brunswick, New Jersey, Forente stater, 08901
    • New York
      • Hawthorne, New York, Forente stater, 10532
      • New York, New York, Forente stater, 10032
      • New York, New York, Forente stater, 10029
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
      • Durham, North Carolina, Forente stater, 27710
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
    • Oregon
      • Portland, Oregon, Forente stater, 97239
    • Pennsylvania
      • Danville, Pennsylvania, Forente stater, 17822
      • Harrisburg, Pennsylvania, Forente stater, 17105
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
    • Texas
      • San Antonio, Texas, Forente stater, 78229
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
      • Milwaukee, Wisconsin, Forente stater, 53226

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion Criteria:

  • Patient has previously received an organ transplant other than a kidney
  • Patient receiving chronic steroid therapy at time of transplant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Legemiddel: takrolimus
muntlig
Andre navn:
  • Prograf, FK506
Legemiddel: mykofenolatmofetil
muntlig
Andre navn:
  • CellCept
  • MMF
Legemiddel: alemtuzumab
Intravenous (IV)
Andre navn:
  • campath
Legemiddel: steroids
IV and/or oral
Aktiv komparator: Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Legemiddel: takrolimus
muntlig
Andre navn:
  • Prograf, FK506
Legemiddel: mykofenolatmofetil
muntlig
Andre navn:
  • CellCept
  • MMF
Legemiddel: steroids
IV and/or oral
Legemiddel: rabbit anti-thymocyte globulin
IV
Andre navn:
  • Thymoglobulin
Eksperimentell: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Legemiddel: takrolimus
muntlig
Andre navn:
  • Prograf, FK506
Legemiddel: mykofenolatmofetil
muntlig
Andre navn:
  • CellCept
  • MMF
Legemiddel: alemtuzumab
Intravenous (IV)
Andre navn:
  • campath
Legemiddel: steroids
IV and/or oral
Aktiv komparator: Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Legemiddel: takrolimus
muntlig
Andre navn:
  • Prograf, FK506
Legemiddel: mykofenolatmofetil
muntlig
Andre navn:
  • CellCept
  • MMF
Legemiddel: steroids
IV and/or oral
Legemiddel: basiliximab
IV
Andre navn:
  • simulect

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
Tidsramme: 6 months

A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).

Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Patient Incidence of BCAR
Tidsramme: End of Study (36 months)

Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Efficacy Failure
Tidsramme: End of Study (36 months)

Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Clinically Treated Acute Rejection
Tidsramme: End of Study (36 months)

Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Time to First BCAR
Tidsramme: End of Study (36 months)

Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Graft Survival at 12 Months
Tidsramme: 12 months

Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.

Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
12 months
Overall Graft Survival
Tidsramme: End of Study (36 months)

Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Patient Survival at 12 Months
Tidsramme: 12 months

Patient survival is defined as not dead within 12 months after skin closure.

Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
12 months
Overall Patient Survival
Tidsramme: End of Study (36 months)

Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Renal Function Abnormalities Based on Creatinine Clearance
Tidsramme: 1 month and End of Study (36 months)

Increases in creatinine clearance usually indicates an improvement.

Change in creatinine clearance from month 1 was calculated.

Change from 1 month is calculated by month 36 - month 1.
1 month and End of Study (36 months)
Renal Function Abnormalities Based on Serum Creatinine
Tidsramme: 1 month and End of Study (36 months)

Decrease in serum creatinine usually indicates an improvement.

Change in creatinine clearance from month 1 was calculated.

Change from 1 month is calculated by month 36 - month 1.
1 month and End of Study (36 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Astellas Pharma Inc

Etterforskere

  • Studieleder: Central Contact, Astellas Pharma Global Development

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2005

Primær fullføring (Faktiske)

1. mars 2009

Studiet fullført (Faktiske)

1. mars 2009

Datoer for studieregistrering

Først innsendt

7. juni 2005

Først innsendt som oppfylte QC-kriteriene

7. juni 2005

Først lagt ut (Anslag)

8. juni 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. august 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. august 2011

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20-04-003

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